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FDA 510(k)

AlignRT Plus (8.0)

K-Number: K253012 · 2026-03-18

ApplicantVision Rt, Ltd.
Decision Date2026-03-18
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AlignRT Plus (8.0) is a medical device manufactured by Vision Rt, Ltd.. It received FDA 510(k) clearance on 2026-03-18 under approval number K253012. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AlignRT Plus (8.0)?

AlignRT Plus (8.0) is a medical device that received FDA 510(k) clearance on 2026-03-18. It is manufactured by Vision Rt, Ltd.. The 510(k) number is K253012.

When was AlignRT Plus (8.0) approved by the FDA?

AlignRT Plus (8.0) received FDA 510(k) clearance on 2026-03-18, under approval number K253012.

What company makes AlignRT Plus (8.0)?

AlignRT Plus (8.0) is manufactured by Vision Rt, Ltd..

What is the FDA product code for AlignRT Plus (8.0)?

The FDA product code for AlignRT Plus (8.0) is IYE.

Other Devices by Vision Rt, Ltd.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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